Is the Treatment Perceived to be Worse than the Disease?: Ethical Concerns and Attitudes towards Psychiatric Electroceutical Interventions

November 2018

About the Project

Dr. Laura Cabrera, whose research focuses on neuroethics, will lead an effort to identify the nature and frequency of ethical concerns, beliefs, and attitudes about four types of psychiatric electroceutical interventions (PEIs) among three key stakeholders groups: psychiatrists, patients, and healthy members of the public, including caregivers.

During the first year of the project, the team will interview psychiatrists, patients and members of the broader public. This qualitative data, along with research already conducted by the team and by other scholars, will guide the team in developing and administering a survey to national samples of psychiatrists, patients, caregivers, and the general public. The survey will contain questions to help the team determine how certain technological characteristics of PEIs (e.g., specificity, adjustability, risk/benefit ratio, and invasiveness) shape ethical concerns, beliefs, and attitudes among the different stakeholders.

The team will then classify and compare their quantitative and qualitative data across stakeholder groups and evaluate the ethical weight of the identified concerns and use its results to develop a comparative analytic map of ethical and social policy challenges to the broader implementation of PEIs in practice.

The significance of this work lies in anticipating potential future policy challenges in ways that will both effectively safeguard sustained ethical PEI development and translation, and benefit individuals affected by mental health disorders.

Students

Technologies

Electroconvulsive therapy (ECT) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of major depressive disorder that has not responded well to other types of therapies (aka, “treatment-resistant” depression). It is also FDA-approved for treating bipolar disorder. During ECT, which is often administered in general hospital psychiatric units and in psychiatric hospitals, patients are given a muscle relaxer and are then put to sleep under general anesthesia. An ECT-trained psychiatrist places electrodes on the patient’s scalp, and electrical current is used to initiate a seizure, which lasts for about a minute. This electrical current delivers the therapeutic effect. Patients usually receive ECT 2-3 times a week for a total of 9-18 treatments. ECT is estimated to produce substantial improvement in depression symptoms for 80% of patients. ECT is effective, but it is not a cure. Most patients usually need some kind of maintenance treatment (which may include ongoing ECT treatment, but may also be psychotherapy and/or medication). ECT works quicker than medications, and is useful for patients who are at a high risk of death due to suicide, failure to thrive, delirium, or catatonia. It is also useful for patients who cannot tolerate other treatments or for whom other treatments have not been effective. Side effects of ECT can include headache, muscle soreness, nausea, and short-term memory difficulties, all of which usually improve within a month of stopping ECT.

Pictured: a machine used to administer electroconvulsive therapy.

Transcranial magnetic stimulation (TMS) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of major depressive disorder that has not responded well to other types of therapies (aka, “treatment-resistant” depression). It is also FDA-approved for treating pain associated with certain migraine headaches. During a TMS session, which is often administered in an outpatient setting, a TMS-certified physician places an electromagnetic coil against the patient’s scalp. This coil delivers repetitive magnetic pulses into areas of the brain associated with mood control, activating regions of the brain that have decreased activity in people with depression. Treatment sessions, which vary in length depending on the TMS coil used and the number of pulses delivered, typically last around 30-40 minutes. A typical course of TMS is done five times a week for 4-6 weeks. However, this can vary depending on an individual’s response to treatment. TMS requires neither surgery nor sedation, and it does not cause seizures. Maintenance treatment with TMS is not always necessary; however, if symptoms recur, TMS treatment can be repeated. TMS appears to be a relatively safe and reasonably well-tolerated treatment. Side effects of TMS are generally mild and include headaches, scalp discomfort, twitching of facial muscles, and lightheadness. Though rare, TMS has the potential for serious side effects including seizures, mania, and hearing loss. TMS is not recommended for people with any metal devices or objects implanted in their bodies.

Pictured: an illustration of a transcranial magnetic stimulation device and the brain.

Deep brain stimulation (DBS) has not yet been approved by the U.S. Food and Drug Administration (FDA) for the treatment of major depressive disorder. However, there currently are ongoing clinical trials to test whether it is effective for depression that has not responded well to other types of therapies (aka, “treatment-resistant” depression). DBS is FDA-approved for treating essential tremor, Parkinson’s disease, obsessive-compulsive disorder, and epilepsy. DBS involves the surgical implantation of electrodes into the brain by a neurosurgeon. These electrodes are connected to a small battery-powered device implanted under the skin of the upper chest. The device delivers electrical stimulation to the brain through the electrodes. DBS therapy may help restore normal activity in brain circuits that are not working properly, acting like a “pacemaker” for the brain. The amount and frequency of the stimulation are customized to the individual patient. Current evidence is inconclusive regarding the efficacy of DBS for depression. Potential side effects include bleeding in the brain, infection, stroke, disorientation or confusion, as well as complications due to hardware malfunction.

Adaptive brain implants (ABIs), which are a newer form of deep brain stimulation (DBS), have not yet been approved by the U.S. Food and Drug Administration (FDA) for the treatment of major depressive disorder. However, there is ongoing discussion regarding its potential use as a treatment for depression that has not responded well to other types of therapies. ABIs have been used for treating epilepsy and are currently undergoing clinical trials for treating Parkinson’s disease. Similar to DBS, the procedure involves the surgical implantation of electrodes in the brain by a neurosurgeon. These electrodes are connected to a small battery-powered device implanted under the skin of the upper chest. The device delivers electrical stimulation to the brain through the electrodes. Like traditional DBS, ABIs may help restore normal activity in brain circuits that are not working properly, acting like a “pacemaker” for the brain. Yet, unlike traditional DBS, which delivers constant stimulation to a part of the brain, ABIs vary the amount of stimulation they deliver in response to the patient’s brain activity. By automatically adjusting the electrical stimulation delivered, future ABIs have the potential to reduce side effects currently seen in DBS.

Pictured: an illustration of a man shows a brain implant with wires leading to two devices in the chest.